Atlas FDA

WINDMERE MASSAGE MATE

FDA 510(k) clearance K933974 · decided 1994-02-02

Clearance details

K-number
K933974
Device name
WINDMERE MASSAGE MATE
Applicant
Windmere Corp.
Decision
Substantially Equivalent
Date received
1993-08-13
Decision date
1994-02-02
Days to decision
173 days
Clearance type
Traditional
Product code
IRO
Device class
1
Regulation number
890.5975
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Miami Lakes, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (K955160)Everapex Design & Marketing Corp.1996-02-08
QI GONG MASSAGER (K955250)East Health Development Group, Inc.1996-02-08
MASSAGER THERAPUTIC, ELECTRIC (K954203)Cisco Sales Corp.1995-12-11
SHIATSU MASTER MASSAGER CUSHION (K952916)Kinsei Shiatsu, Inc.1995-08-28
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (K951414)Champion Mfg. Corp.1995-08-11
CONAIR FAMILY FITNESS BODY ENERGY (K950441)Conair Corp.1995-07-18
SKALPI 3200 (K946382)Wiscco Development, Inc.1995-05-30
CONAIR BODY AND SOLE (K950410)Conair Corp.1995-05-23
WAHL FRESH FACE (K944909)Wahl Clipper Corp.1995-05-08
HAND MASSAGE UNIT (K950400)Ultrassage, Inc.1995-03-30
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) (K945603)Headwaters, Inc.1995-02-09
MASSAGING HELMET C.F. HANSEN DESIGN (K940582)Philco Ushuaia1995-01-30

Recalls involving this device

No recalls on record reference this clearance.